MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PACK GYN LAPAROSCOPY CHRG

Catalog Number	DYNJ60236C
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "account is still having repeat issues with the drape.Pouch adhesive issue, its definitely the adhesive not being strong enough.The adhesive giving way and pouches tearing off.".
Additional Manufacturer Narrative
The account reported finding drape pouch adhesive issue, with the adhesive giving way and pouches tearing off.A photo was received for investigation and showed a used drape with pouch; the pouch was not fully adhered to the drape, only one corner of the pouch was seen to be adhered to the drape, and there was one slight tear at the corner of the pouch near the adhesive.Per review of the photo provided, medline confirmed that the pouch was separating away from the drape and tearing.The root cause was considered to be a vendor product issue relating to the component manufacturing process; the vendor determined the root cause to be insufficient adhesion of the double-sided tape, and no patient injury or adverse event was reported.There were no reports of death, serious injury, medical intervention, or follow up care.This is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: PACK GYN LAPAROSCOPY CHRG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872363
• Report Number: 1417592-2026-49289
• Device Sequence Number: 10674111
• Product Code: OHD
• UDI-Device Identifier: 10195327680398
• UDI-Public: 10195327680398
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ60236C
• Device Lot Number: 25AMI541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown